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3.
Trials ; 22(1): 62, 2021 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-33461595

RESUMO

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.


Assuntos
Academias e Institutos/organização & administração , Ensaios Clínicos como Assunto/organização & administração , Pessoal Administrativo , Ensaios Clínicos Fase III como Assunto , Controle de Doenças Transmissíveis , Comunicação , Coleta de Dados , Hospitais Universitários , Humanos , Irlanda , Liderança , Pacientes Desistentes do Tratamento , Seleção de Pacientes , Admissão e Escalonamento de Pessoal , Política Pública , Pesquisadores , Sujeitos da Pesquisa
4.
J Nepal Health Res Counc ; 18(4): 807-809, 2021 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-33510536

RESUMO

In the race for a safe and effective vaccine against Coronavirus disease-19 manufacturer plays a critical role throughout the development, clinical trial, manufacturing, supply, and vaccination phases. For the efficacy of Coronavirus disease-19 vaccine, proper transport, storage, vaccine carrier, adjuvant, dosage form and route of vaccine administration plays a crucial role for immune response. In the context of no more people were willing to pay for a Coronavirus disease-19 vaccine the logistics of manufacturing, storing and distributing the vaccine, and mass vaccination are essential. It is urgent to improve health promotion and reduce the barriers to Coronavirus disease-19 vaccination. Keywords: COVID-19; vaccine development; vaccination.


Assuntos
/provisão & distribução , /prevenção & controle , Indústria Farmacêutica/organização & administração , Ensaios Clínicos como Assunto/organização & administração , Desenvolvimento de Medicamentos/organização & administração , Humanos , Vacinação em Massa/organização & administração , Nepal/epidemiologia
10.
Ann Pharm Fr ; 78(6): 464-468, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33038310

RESUMO

On January 4 2020, the World Health Organization (WHO) reported the emergence of a cluster of pneumonia cases in Wuhan, China due to a new coronavirus, the SARS-CoV-2. A few weeks later, hospitals had to put in place a series of drastic measures to deal with the massive influx of suspected COVID-19 (COronaroVIrus Disease) patients while securing regular patient care, in particular in the intensive care units (ICU). Since March 12th, 77 of the 685 COVID-19 patients admitted to our hospital required hospitalization in the ICU. What are the roles and the added-value of the critical care pharmacist during this period? His missions have evolved although they have remained focused on providing health services for the patients. Indeed, integrated into a steering committee created to organize the crisis in the intensive care units, the role of the clinical pharmacist was focused on the organization and coordination between ICU and the pharmacy, the implementation of actions to secure practices, to train new professionals and the adaptation of therapeutic strategies. He participated to literature monitoring and increased his involvement in the clinical research team. He provided a link between the ICU and the pharmacy thanks to his knowledges of practices and needs.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Cuidados Críticos , Pandemias , Farmacêuticos , Pneumonia Viral/epidemiologia , Ensaios Clínicos como Assunto/organização & administração , Membro de Comitê , Equipamentos e Provisões Hospitalares/provisão & distribução , França , Humanos , Serviços de Informação , Armazenamento e Recuperação da Informação , Comunicação Interdisciplinar , Descrição de Cargo , Administração de Materiais no Hospital , Segurança do Paciente , Preparações Farmacêuticas/provisão & distribução , Serviço de Farmácia Hospitalar/organização & administração , Papel (figurativo)
13.
J Alzheimers Dis ; 77(4): 1805-1813, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32986671

RESUMO

BACKGROUND: The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. OBJECTIVE: To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. METHODS: We describe participants' clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. RESULTS: A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. DISCUSSION: The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.


Assuntos
Doença de Alzheimer/terapia , Ensaios Clínicos como Assunto , Infecções por Coronavirus , Pandemias , Assistência ao Paciente , Pneumonia Viral , Idoso , Instituições de Assistência Ambulatorial , Betacoronavirus , Técnicas de Laboratório Clínico , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Assistência ao Paciente/métodos , Assistência ao Paciente/tendências , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Espanha/epidemiologia , Telemedicina/métodos , Terapias em Estudo/métodos
14.
J Addict Med ; 14(6): e297-e302, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32956164

RESUMO

: As a result of the coronavirus 2019 (Covid-19) pandemic, clinical research for substance use disorders (SUDs) has been impeded due to widespread stay-at-home mandates limiting the operations of "non-essential" work. Although appropriate to proceed with an abundance of caution to prevent viral spread, there will be detrimental consequences for patients with SUDs if clinical trials research cannot adapt and continue uninterrupted. The field of digital health has strong evidence for its feasibility and effectiveness and offers tools that can facilitate the continuation of SUD clinical trials research remotely in accordance with Covid-19 precautions. Some digital tools have been used as components of SUD research in the past; however, no published clinical trial in SUDs to-date has been entirely virtual. This has important implications for disrupted clinical care, as providers seek guidelines for best digital practices. This paper provides a roadmap for integrating the fields of digital health and SUD clinical trials by proposing methods to complete recruitment, screening, informed consent, other study procedures, and internal lab operations digitally. The immediate future of SUD research depends on the ability to comply with social distancing. Investment in research of digital clinical trials for SUDs provides an opportunity to cultivate benefits for research and clinical care long-term as we can (1) define regulatory requirements for the implementation of digital systems, (2) develop consensus on system-wide standards and protocols in the appropriate use of technology, and (3) gain experience that can translate to the treatment of patients with SUDs through telehealth in the community.


Assuntos
Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/terapia , Telemedicina/métodos , Ensaios Clínicos como Assunto/organização & administração , Infecções por Coronavirus/prevenção & controle , Humanos , Controle de Infecções/métodos , Consentimento Livre e Esclarecido , Pandemias/prevenção & controle , Seleção de Pacientes , Pneumonia Viral/prevenção & controle
16.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(9): 915-917, 2020 Sep 06.
Artigo em Chinês | MEDLINE | ID: mdl-32907278

RESUMO

Development of an effective vaccine requires a long and complicated process. Preclinical studies and phase Ⅰ, Ⅱ, Ⅲ clinical trials mainly focused on the assessment of the vaccine's safety (tolerability), immunogenicity and efficacy before license. After license, it is necessary to further evaluate the actual effectiveness and safety in the general population through phase Ⅳ clinical trials and optimize the immunization strategies with the disease's epidemiology data. In this special issue, published several articles, which reported the main results of pre-license clinical trials and post-marketing evaluation of various vaccines, it was extremely useful to support vaccine licensing and market use. We encourage the continuous clinical studies and post-marketing evaluation of vaccines, including the novel corona virus-19 vaccines, to provide technical support for the population use, under the situation of COVID-19 pandemic.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Imunização/métodos , Vacinas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Vacinas Virais
17.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(9): 963-967, 2020 Sep 06.
Artigo em Chinês | MEDLINE | ID: mdl-32907286

RESUMO

Objective: To evaluate and share the novel method for recruiting participants in clinical trials of vaccines in emergency situations. Methods: To publish recruitment notice in local areas of Wuhan through websites and medium, and guide interested persons to log in to the"Clinical Trials of SARS-CoV-2 Vaccine Reservation and Health Declaration System"to appoint and register their health information. The "Health Declaration System" provides each volunteer evaluation and risk levels to preliminarily exclude those who do not meet the inclusion criteria. Researchers review the qualified volunteers by telephone, organize them to go to the vaccination site, and finally conduct a strict medical screening to determine the final subjects. Results: A total of 4 819 people and 5 132 people registered in the Phase Ⅰ and Phase Ⅱ recruitment system respectively, with men 2 912 (60.43%) and 2 887 (56.25%) more than women 1 907 (39.57%) and 2 245 (43.75%), mostly in the 20-39 age group, with 3 211 (66.63%) and 3 966 (77.28%). All 13 districts in Wuhan have interested residents to participate clinical research.The initial qualified rate of the Phase Ⅱ recruitment system was higher than that of Phase Ⅰ, with men 2 047 (70.28%) and 2 135(73.95%), higher than women 1 083 (56.80%) and 1 472 (65.57%); 440 and 689 people were reviewed by telephone in Phase Ⅰ and Phase Ⅱ respectively, and the number of verified volunteers was about 440 (35.00%) and 689 (67.20%); Of the 201 603 people who arrived at the vaccination site, 12 and 26 of them were positive for the SARS-CoV-2 antibody with an antibody positive rate of 6.00% and 4.31% respectively. Conclusion: The novel method for recruiting subjects in this clinical study is efficient and reliable, and the recruitment situation of Phase Ⅰ had set a good example for Phase Ⅱ but the medium-and long-term compliance of subjects and the separation of willingness and behaviors still need to be further studied.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Seleção de Pacientes , Vacinas Virais , Adulto , China/epidemiologia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Emergências , Feminino , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Voluntários/estatística & dados numéricos , Adulto Jovem
19.
Pediatrics ; 146(4)2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32943534

RESUMO

The National Institutes of Health's Environmental Influences on Child Health Outcomes (ECHO) program aims to study high-priority and high-impact pediatric conditions. This broad-based health initiative is unique in the National Institutes of Health research portfolio and involves 2 research components: (1) a large group of established centers with pediatric cohorts combining data to support longitudinal studies (ECHO cohorts) and (2) pediatric trials program for institutions within Institutional Development Awards states, known as the ECHO Institutional Development Awards States Pediatric Clinical Trials Network (ISPCTN). In the current presentation, we provide a broad overview of the ISPCTN and, particularly, its importance in enhancing clinical trials capabilities of pediatrician scientists through the support of research infrastructure, while at the same time implementing clinical trials that inform future health care for children. The ISPCTN research mission is aligned with the health priority conditions emphasized in the ECHO program, with a commitment to bringing state-of-the-science trials to children residing in underserved and rural communities. ISPCTN site infrastructure is critical to successful trial implementation and includes research training for pediatric faculty and coordinators. Network sites exist in settings that have historically had limited National Institutes of Health funding success and lacked pediatric research infrastructure, with the initial funding directed to considerable efforts in professional development, implementation of regulatory procedures, and engagement of communities and families. The Network has made considerable headway with these objectives, opening two large research studies during its initial 18 months as well as producing findings that serve as markers of success that will optimize sustainability.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Área Carente de Assistência Médica , Pediatria , Apoio à Pesquisa como Assunto/organização & administração , População Rural , Fortalecimento Institucional , Saúde da Criança , Ensaios Clínicos como Assunto/economia , Educação Continuada , Humanos , Apoio à Pesquisa como Assunto/economia , Estados Unidos
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